Povidone Iodine

PEP Topic

Mucositis

Description

Povidone iodine is a chemical complex of povidone and elemental iodine. It is an antiseptic. It has been widely used as a pre-operative skin cleansing agent and for the treatment and prevention of infection in wounds. Povidone iodine in the form of an oral rinse has been evaluated in patients with cancer for prevention and treatment of mucositis.

Effectiveness Not Established

Systematic Review/Meta-Analysis

Kwong, K.K. (2004). Prevention and treatment of oropharyngeal mucositis following cancer therapy: Are there new approaches? Cancer Nursing, 27(3), 183–205.

Search Strategy:

Literature Evaluated:

A total of 50 randomized controlled trials were presented. Other trials and papers were referenced.

Sample Characteristics:

Sample sizes ranged from 10–222.

Patients were treated with chemotherapy, radiotherapy, and bone marrow transplantation.

Conclusions:

The author concluded that most agents require more study.

Evidence for cryotherapy and bolus 5-fluorouracil was strong.

Sucralfate studies produced conflicting results and included varying doses and administration frequencies, making comparisons difficult. Most studies indicated no difference in severity or duration. The validity and reliability of the data were questioned because of the measurement scales used.

Moderate evidence suggested that benzydamine is effective in relieving mouth pain caused by radiation-induced mucositis in patients with head and neck cancer. The agent requires additional investigation and study for chemotherapy-induced mucositis.

Large studies of chlorhexidine mouthwashes have failed to show significant findings; however, the studies may have had inadequate sample sizes, as power analyses were not performed.

Povidone-iodine showed significant reduction in onset, incidence, total duration, and worst grade of mucositis for patients with head and neck cancer undergoing radiation with carboplatin in two studies. Both studies had sample sizes of 40. Given these sample sizes and specific populations, generalizability of the findings was restricted.

Oral hygiene protocols were shown to reduce the duration and severity of mucositis; however, the content of the protocols was not proven.

Limitations:

The author noted the problem of variation in study protocols, insufficient sample sizes, and a lack of consensus regarding the scoring system for mucositis.

Nursing Implications:

The author noted the need to include psychotherapeutic interventions and management and pointed out the lack of a quality-of-life tool for mucositis.

Research Evidence Summaries

Madan, P.D., Sequeira, P.S., Shenoy, K., & Shetty, J. (2008). The effect of three mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies: A randomized control trial. Journal of Cancer Research Therapies, 4(1), 3–8.

Intervention Characteristics/Basic Study Process:

Coloring agents, sweeteners, and flavoring agents were added to the mouthwashes so that all had identical color and taste. All were alcohol free.

Patients rinsed mouths with 10 ml of mouthwash BID for six weeks. Patients swished for about two minutes and expectorated, then abstained from eating or gargling for 30 minutes.

Sample Characteristics:

The study was comprised of 20 patients in each arm of study.

Adult patients with stage II–IV head and neck malignancy scheduled to receive RT of 60 Gy or higher, delivered in 30 fractions over a six-week period.

At least one-third of oral cavity mucosa was included in the radiation field.

Powered for 20 subjects in each arm; 76 completed.

The median age was 54.25–58.2 years.

More men participated than women.

Setting:

July 2003–January 2004

Study Design:

Double-blind, placebo-controlled, randomized clinical trial

Measurement Instruments/Methods:

Compliance was assessed weekly by checking the level of mouthwash left in bottles.

Mucositis WHO– single examiner

Primary endpoint of study was the end of week 6.

Results:

Significant difference in mean mucositis scores was observed among all four groups. Post hoc analysis for repeated measure showed a statistically significant difference between the povidone group and control group (p = 0.013) at the end of week 1.

At the end of week 2, povidone, chlorhexidine, and salt/soda groups differed significantly from the control group.

At the end of week 4, significant differences also were observed between the povidone and salt/soda groups (p = 0.16).

At the end of week 5, significant differences were observed between all test groups and the control group. Differences also were observed within test groups.

At the end of week 6, a slightly different trend was observed. Significant differences were observed between the povidone group and all other groups; difference in mucositis among other groups was not statistically significant.

Limitations:

Although the volume of solution used was checked weekly, data does not indicate compliance.

Study Purpose:

The goal of the study was to define the role of anti-microbial solutions.

Intervention Characteristics/Basic Study Process:

Two groups of patients were compared: Normal saline mw povidone-iodine mw.
Group A used NS for oral rinsing and Group B use povidone-iodine diluted 1:100 water. The solutions were blinded to patients. Study nurse started first day and covered the whole inpatient stay. It was a 2 min gargle 4x/day IN the presence of OM the mouthwashes could be more frequent according to patients' wishes. Used soft toothbrush 4 x/day. If bleeding occurred would do only MW

Mouthwash was blinded.

Sample Characteristics:

The study was comprised of 132 patients. Patients were treated with hi-dose BEAM or HD-LPAM followed by APSCT.

Study group A had 65 pts or group B had 67 patients, NS or povidone iodine.

Setting:

Multicenter

Jan 2002- June 2004

Study Design:

Prospective, randomized

Measurement Instruments/Methods:

OM assessed daily

WHO scale

VAS for tolerability

Temp, oral smears

Blood cultures with fever

Results:

No significant difference with oral mucositis (p = 1.0) characteristics in both groups and fever of unknown origin (p = 1.0) and other infections (p = 0.34). Povidone-iodine was less tolerable.

No healing effect with betadine.

OM occurred more significantly in females than in males (p = .0016) and was worse and of longer duration.

Nursing Implications:

Patients disliked the taste of povidone-iodine, less use of povidone-iodine.

Intervention Characteristics/Basic Study Process:

All patients received initial tooth brushing with a dental brush by a dentist and scaling to teeth with an ultrasonic scaler.

Special care group:
Dentist performed oral care with irrigation and suctioning for 15 minutes three days per week for two to four weeks between 7:00 pm and 8:00 pm after dinner. 20 ml of 0.5% povidone-iodine was ejected through the e-brush, then suctioned. This was done in the mouth, sides of the teeth, tongue, and mucosal surfaces. Patients rinsed with 0.5% povidone-iodine to clean the oral cavity. A combination of physical and chemical cleaning was used.